Breast-Milk Enema Administration to Stimulate Meconium Passage in Preterm Infants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Lack of passage of meconium in preterm infants delays feeding advancement and may represent a risk factor for necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP). Usual management of meconium impaction has included glycerin suppositories and normal saline enemas. Various methods are used in routine neonatal care to promote meconium evacuation; however, there is no consensus on the agents used and the frequency of applications
详细描述
Breast milk is a natural oil-in-water emulsion that can soften meconium, lubricate, and stimulate the intestinal wall, making it easier to excrete meconium. The osmotic pressure of breast milk is a benign stimulus to the digestive tract of premature infants. In addition, breast milk contains bioactive compounds that may positively influence gut motility and the microbiome and has been shown to decrease the incidence of NEC. A small-volume rectal enemas using mother's own breast milk in preterm infants born at <28 weeks' gestation with delayed passage of meconium (>48 hours of life) are feasible and safe, and may be associated with earlier meconium passage and improved early feeding outcomes without increasing the risk of necrotizing enterocolitis (NEC) or other gastrointestinal complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 23 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at >23 and <28 weeks' gestational age born at Atrium Health Wake Forest Baptist Hospital or transferred in the first 24 hours of life.
- •postnatal age >48 hours, absence of spontaneous passage of meconium by >48 hours of life
- •availability of mother's own milk
- •written informed consent obtained from a parent or legal guardian.
排除标准
- •Infants with Necrotizing Enterocolitis (NEC) ≥ stage II
- •spontaneous intestinal perforation (SIP)
- •gastrointestinal or anorectal malformations
- •infants that have developed severe hemodynamic instability or sepsis with need for vasoactive drugs
- •significant hematologic abnormalities such as neutropenia or thrombocytopenia.
- •Infants will also be excluded in the absence of written informed consent from a parent or legal guardian.
研究组 & 干预措施
breast milk
A small-volume rectal enema consisting of 5 mL/kg of fresh mother's own breast milk will be administered as a single dose, with the option for one repeat dose at 24 hours if clinically indicated. The prescribed enema volume (5 mL/kg) will be calculated based on current weight and warmed to 37 °C using an approved breast milk warmer.
干预措施: breast milk (Drug)
结局指标
主要结局
未指定
次要结局
- Total length of hospital stay(Day 120)
- Number of central line days(Day 120)